Search by Drug Name or NDC

NDC 60760-0671-60 Stool Softener 100 mg/1 Details

Stool Softener 100 mg/1

Stool Softener is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by St Mary's Medical Park Pharmacy. The primary component is DOCUSATE SODIUM.

MedlinePlus Drug Summary

Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoids, and other problems. They work by softening stools to make them easier to pass.

Related Packages: 60760-0671-60
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	60760-0671
Product ID	60760-671_9378e93e-48ce-0ef8-e053-2995a90aec4d
Associated GPIs	46500010300110
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Stool Softener
Proprietary Name Suffix	n/a
Non-Proprietary Name	Docusate Sodium
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/1
Substance Name	DOCUSATE SODIUM
Labeler Name	St Mary's Medical Park Pharmacy
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2022-12-31

Package

Package Images

NDC 60760-0671-60 (60760067160)

Pricing Information	N/A
NDC Package Code	60760-671-60
Billing NDC	60760067160
Package	60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (60760-671-60)
Marketing Start Date	2019-09-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9378d716-dffc-48fb-e053-2995a90a37fb Details

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• have a sudden change in bowel habits that persists over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement. These

could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor

• children under 12: consult a doctor

• do not exceed recommended dose

Other information

• each softgel contains: sodium 5 mg. very low sodium

• store at 15°C-25°C(59° F-77° F)

• keep tightly closed

• product from USA or Canada

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

FD and C red 40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow 10, FD and C yellow 6 (sunset yellow), mannitol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STOOL SOFTENER

docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60760-671(NDC:57896-401)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	red (reddish)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SCU1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60760-671-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/26/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/26/2019

Labeler - St Mary's Medical Park Pharmacy (063050751)

Name	Address	ID/FEI	Business Operations
Establishment
St. Mary's Medical Park Pharmacy		063050751	relabel(60760-671) , repack(60760-671)

Revised: 9/2019

Document Id: 9378e93e-48ce-0ef8-e053-2995a90aec4d

Set id: 9378d716-dffc-48fb-e053-2995a90a37fb

Version: 1

Effective Time: 20190926